DuraMatrix Onlay

GUDID 00813954020280

Collagen Dura Substitute Membrane 5in x 7in (12.5cm x 17.5cm)

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant
Primary Device ID00813954020280
NIH Device Record Key286d3c1a-76dc-48be-a24c-e45ab14077eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraMatrix Onlay
Version Model NumberCDSLM57
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length5 Inch
Length5 Inch
Length5 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch
Width7 Inch
Length5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954020280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXQDura Substitute

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-11
Device Publish Date2015-09-16

On-Brand Devices [DuraMatrix Onlay]

00813954020280Collagen Dura Substitute Membrane 5in x 7in (12.5cm x 17.5cm)
00813954020273Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
00813954020266Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm)
00813954020259Collagen Dura Substitute Membrane 2in x 2in (5cm x 5cm)
00813954020242Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)
00813954020235Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm)

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